Study of Relationship Between UGT1A1 Gene Polymorphism an... | NCT01635400

Studies
Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer

NCT01635400

Sponsor

Zhejiang Cancer Hospital

Status

Unknown status

Last Update Posted

Jul 9, 2012Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Small Cell Carcinoma of Lung

Interventions

Irinotecan

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Jun 27, 2012

First Submission Date that Met QC Criteria

Jul 6, 2012

First Posted Date

Jul 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2012

Last Update Posted Date

Jul 9, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to find out the correlation between uridine diphosphate glucuronosyl transferase 1A1(UGT1A1) gene polymorphisms and the side effect and efficacy of irinotecan in patients with small cell lung cancer.

Detailed Description

In multiple studies of metastatic colorectal cancer,uridine diphosphate glucuronosyl transferase 1A1(UGT1A1) gene polymorphisms and its correlation with irinotecan-associated side effects have been confirmed.Data from several studies indicated an improved clinical outcome of patients who had received an irinotecan-based regimen.In order to find out the correlation between UGT1A1 gene polymorphisms and the side effect and efficacy of irinotecan in patients with small cell lung cancer,we designed this study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
UGT1A1 wild type (6/6)	Other	Drug: Irinotecan
UGT1A1 heterozygous genotype (6/7)	Other	Drug: Irinotecan
UGT1A1 homozygous genotype(7/7)	Other	Drug: Irinotecan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Irinotecan	Drug	irinotecan 180mg/m2 i.v. over 30 min d1,q2w	UGT1A1 heterozygous genotype (6/7) UGT1A1 homozygous genotype(7/7) UGT1A1 wild type (6/6)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Side effect of chemotherapy	myelosuppression,diarrhea	within the first 30 days (plus or minus 3 days) after chemotherapy

Secondary Outcomes

Measure	Description	Time Frame
response rate of chemotherapy		tumor assessments after two cycles of chemotherapy,an expected average of 6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of refractory or relapsed small cell lung cancer
Physical examination and routine laboratory tests show no contraindications to chemotherapy

Exclusion Criteria:

Pregnant and nursing women
Brain metastasis with symptoms

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fan Yun	Contact	86057188122192		fanyun@csco.org.cn

Overall Officials

Name	Affiliation	Role
Fan Yun	Zhejiang Cancer Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhejiang Cancer Hospital	Recruiting	Hangzhou	Zhejiang		China

Condition Browse Module

MeSH Terms

ID	Term
D055752	Small Cell Lung Carcinoma

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077146	Irinotecan

Ancestor Terms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided